The Food and Drug Administration’s Acting Commissioner of Food and Drugs Norman E. "Ned" Sharpless, and Director of the Center for Drug Evaluation and Research, Janet Woodcock, released a joint statement regarding the agency’s commitment to making sure that healthcare professionals and patients have up-to-date, accurate and actionable information about prescription medications so that informed treatment decisions can be made.
The agency says it is working to help ensure that FDA-approved medication and biological product labeling (often referred to as the “package insert” or Prescribing Information) provides clear, complete information so that healthcare professionals have the essential information needed to make informed decisions and to facilitate safe and effective use of a medication. In this effort, new draft guidances have been issued
The pair underscored that that the choice of which medication to use, if any, for a patient is often a complex decision involving several factors, such as:
· assessing the progression of the disease or condition
· looking at the other medications being taken
· evaluating the ability of the patient to follow treatment regimens and instructions to help ensure safe use of a medication
· assessing (sometimes) the risk of abuse and dependence of a medication for a particular patient
FDA says one area of patient counseling that is incredibly important within a discussion about a product’s benefits and risks is the potential for abuse and the development of a physical dependence to a prescription drug. This is relevant in the context of prescription opioids for treating pain, but it’s important for patients to understand that other drugs can be habit-forming as well – for example, certain medications used to treat insomnia and some medications used to treat attention deficit hyperactivity disorder.
A new draft guidance, Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products - Content and Format, when finalized, will represent FDA’s current thinking on the content and format of this section for prescription medications that are scheduled under the Controlled Substances Act (CSA) as well as for prescription medications not scheduled under the CSA for which there is important information to convey to healthcare professionals related to abuse and dependence.
This guidance is intended to help ensure that information in product labeling on abuse, misuse, addiction, physical dependence and tolerance is clear, concise, useful and informative. Details about a product’s abuse-deterrent properties should also be presented in this section, when applicable. Additionally, the draft guidance provides recommendations on how to present information about applicable drug products in a consistent manner where possible within, and across, drug and therapeutic classes to inform decisions and facilitate the safe and effective use of medications.
This draft guidance reinforces these principles by recommending, for example, that terminology used in the Drug Abuse and Dependence section – such as abuse, misuse, addiction, physical dependence and tolerance – be defined in labeling to ensure common understanding. Because these terms are commonly confused or misinterpreted, the FDA has included recommended definitions for the purposes of labeling. The draft guidance clarifies, for example, that a person who takes a friend’s prescription opioid medication to relieve tooth pain is misusing the medication; if that person takes a friend’s opioid to get a euphoric high, that use represents abuse of the medication.
In another example, recently the FDA announced required changes to the prescribing information for all opioid analgesics to provide additional information to healthcare professionals on how to safely decrease the treatment dose in patients who are physically dependent on opioids. The FDA remains focused on striking the right balance between reducing the rate of opioid use disorder by decreasing excessive exposure to opioids through rational prescribing, while still enabling appropriate access to treatment for patients living with pain. FDA also says it is committed to making sure that patients who use opioids take them correctly, and, if opioid treatment is no longer needed, that patients and their healthcare providers know how to discontinue the medication safely.
FDA also issued a second draft guidance, Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format, which relates to how the drug or biologic is used. The Instructions for Use (IFU) is a type of labeling for patients who use products that have complicated or detailed patient-use instructions. Importantly, an IFU provides detailed, action-oriented, step-by-step written and visual instructions in a patient-friendly manner to guide the patient on how to use a prescription medication product. It typically includes instructions on preparation, administration, handling, storage and disposal. The recommendations in this draft guidance are intended to promote development of consistent content and format across IFUs to help ensure that patients receive clear, concise information that is easily understood to facilitate the safe and effective use of such products.
